Accord Logo

Intended for UK patients and members of the public

PIL- Baclofen Tablets BP 10mg: Change history

  • To update sections 4.4 and 4.8 of the SPC in line with the

    reference product Lioresal Tablets 10mg - PL 00101/0504

    (MAH: Novartis Pharmaceuticals UK Limited). Consequently,

    the PIL has been updated

    • Changes: (Updated: 02 Dec 2024)

      To update sections 4.4 and 4.8 of the SPC in line with the

      reference product Lioresal Tablets 10mg - PL 00101/0504

      (MAH: Novartis Pharmaceuticals UK Limited). Consequently,

      the PIL has been updated

    • Changes: (Updated: 25 Sep 2024)

      To update sections 4.4 to add warnings of Encephalopathy. To update 4.8 to include Encephalopathy in SOC nervous system disorders in frequency not known. Aswell as an update to section 4.9 to include Encephalopathy and Generalised slowing on EEG in the symptoms of overdose all in line with PSUSA/00000294/202309. The PIL has been updated accordingly

    • Changes: (Updated: 20 Dec 2022)

      PIL sections updated – Heading, index, 1, 2, 3, 4, 5 and 6.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

    View product information as a: